Patients with relapsed and refractory multiple myeloma lived roughly 3.6 months longer without their disease worsening when they received a once-weekly dose of Amgen’s Kyprolis (carfilzomib) compared to a twice-weekly dose, according to an interim analysis of a Phase 3 trial.
Both treatment regimens included the administration of dexamethasone, a steroid commonly used to treat inflammation. The overall safety profile of once-weekly Kyprolis was similar to that of the twice-weekly regimen.
The clinical trial – called ARROW (NCT02412878) – includes 478 patients with relapsed and refractory multiple myeloma who had already received two or three lines of therapy, which included a proteasome inhibitor and an immunomodulatory agent (IMiD).
The trial is estimated to be completed in December 2019, with the final data collection expected in June 2019.
Proteasome inhibitors like Kyprolis allow the build-up of faulty proteins inside cells, which kills them. IMiDs are drugs that adjust immune responses in inflammatory diseases and malignancies.
Patients in the trial were randomized to a once-weekly 70 mg/m2 dose of Kyprolis plus dexamethasone, or twice-weekly 27 mg/m2 dose, also with dexamethasone.
The trial’s main goal was to determine the time to disease progression or death. Secondary endpoints included overall response rate, overall survival, and safety, along with several other lab parameters.
Patients treated with the once-weekly Kyprolis regimen lived significantly longer without disease progression than those receiving the twice-weekly regimen (11.2 months vs. 7.6 months). This represented a 31 percent difference.
Adverse events from the treatment experienced by 20 percent or more of patients on either dose of Kyprolis included anemia (low iron in the blood), diarrhea, fatigue, high blood pressure, insomnia, and fever.
Kyprolis is approved in the U.S. for use in combination with dexamethasone, or with Celgene’s Revlimid (another proteasome inhibitor) plus dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
It is also approved as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have already received one or more lines of therapy.
It is also approved in the European Union and many other countries around the world, including Japan, Australia, Russia, and countries in the Mideast.
“Kyprolis has been demonstrated to be the most effective proteosome inhibitor available to patients with multiple myeloma,” Dr. Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release.
“We are encouraged by the efficacy and safety profile of Kyprolis and dexamethasone administered once-weekly in the ARROW study,” he added.